About the role

As the Manufacturing Engineer, you will oversee all aspects of product manufacturing and operation, collaborating closely with engineering teams and suppliers to establish efficient processes. Your role will involve designing, engineering, validating, manufacturing, and testing fixtures and documenting and refining reliable processes for component and system-level assemblies. You will also ensure compliance with regulatory standards, fostering efficiency and excellence throughout the production lifecycle.

What you'll do

Define and establish manufacturing processes, procedures, and production layouts for parts and assemblies, ensuring regulatory compliance.
Provide hands-on leadership, on-the-job training, and technical support for production staff on the production line during production ramp-up.
Define, implement, and continuously refine manufacturing KPIs and dashboards (yield, throughput, cycle time, cost/unit, scrap, on-time delivery), establishing clear methods to track performance and drive data-informed decisions.
Lead scale-up of manufacturing operations, identifying bottlenecks, optimizing workflows, and building efficient, repeatable processes that support rapid growth while maintaining quality and regulatory compliance.
Own capacity planning and production forecasting, translating demand into actionable production targets and quotas; leverage data analysis to improve efficiency, reduce costs, and ensure predictable, scalable output.
Develop and incorporate. inspection and test requirements into production plans through the development of process FMEA and other applicable Risk Management documents
Design and develop test fixtures for engineering and manufacturing applications.
Define the asMaster Validation Plan and support validation builds and testing
Oversee the complete documentation process for DMR and DHR, including manufacturing work instructions, inspection and test specifications, and travelers. Ensure accurate data entry and seamless management within the quality and MRP database platform.
Identify process and design improvements to reduce manufacturing costs and increase efficiency.
Provide technical support for failure analysis of discrepant production components, assemblies, equipment/tools, as well as field returns; initiate corrective actions to ensure product quality.
Offer strategic guidance to leadership on manufacturing build strategies, capacity expansion, and overall operations planning.
Identify, research, develop, and qualify premier part manufacturers and suppliers; establish supply chain requirements and manage supplier relationships.
Report on key metrics and KPIs regularly.
Significant exposure to the board and management team, as well as the industry-leading investors and thought leaders.
Travel up to 20% as a regular basis

Qualifications

Bachelor’s degree in mechanical, electrical, biomedical, industrial, or materials science engineering (preferred).
Must work in the Sunnyvale office 4-5 days a week
Minimum 3+ years of experience in medical device manufacturing.
Proven ability to succeed in a hands-on role and take the initiative.
Proficiency in CAD software (e.g., SolidWorks, Pro-Engineer).
Strong understanding of manufacturing processes (e.g., injection molding, machining, stamping, laser welding, ultrasonic welding).
Solid foundation in the design, fabrication, and assembly of complex electromechanical assemblies, including knowledge of mechanical assembly techniques and test methods (e.g., gage R&R analysis, DFx, and lean principles).
Strong technical skills in prototyping, tooling development, process engineering, and troubleshooting.
Excellent communication skills to effectively interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing, and supplier teams.
Strong interpersonal skills with the ability to lead and inspire teams.
Demonstrated ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of quality

Preferred Qualifications

Experience in electromechanical new product development.
Background in ISO 13485 medical device manufacturing or a similar regulated industry.
Experience collaborating with electrical and systems engineers to design automated PCBA test fixtures.
Proficiency in process characterization and validation using statistical tools.

Why Join Us?

At iSono Health, we're changing the future of breast cancer detection. Our technology empowers clinics of all sizes to deliver fast, affordable, and comfortable breast imaging at the point of care, using the world’s first AI-powered, portable 3D ultrasound system.

As our Manufacturing Engineer, you’ll play a pivotal role in bringing this life-saving innovation to the world. You'll work on cutting-edge, FDA-cleared technology in a mission-driven environment where your contributions directly impact women's health. You’ll lead manufacturing strategy, improve production processes, and collaborate with a cross-functional team committed to quality, innovation, and accessibility.

We are a growing startup with a bold vision: to make early detection effortless and accessible for everyone. If you're excited to help scale a high-impact product, love solving complex challenges, and want your work to matter, this is the place for you.

Join us in transforming breast imaging and saving lives, one scan at a time.

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